Proposal for a Council Regulation laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency - Main contents

Document date	27-06-2014
Publication date	29-06-2014
Reference	5802/3/14 REV 3
From	General Secretariat of the Council
External link	original article
Original document in PDF

COUNCIL OF Brussels, 27 June 2014

THE EUROPEAN UNION

5802/3/14

Interinstitutional File: REV 3

2013/0451 (NLE) i

ATO 9 AGRI 48 COMER 24

NOTE from: General Secretariat of the Council to: Delegations No. Cion prop.: 5190/14 ATO 3 AGRI 6 COMER 6 + ADD 1 Subject: Proposal for a Council Regulation laying down maximum permitted levels of

radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency

Delegations will find attached the revised text of the above proposal. This document will be considered by the WPAQ on 9 July 2014.

____________________

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DG E EN

ANNEX

Proposal for a

COUNCIL REGULATION

laying down maximum permitted levels of radioactive contamination of food and feed following a nuclear accident or any other case of radiological emergency

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Atomic Energy Community, and in particular Articles 31 and 32 thereof, Having regard to the proposal from the European Commission, drawn up after obtaining the opinion of the group of persons appointed by the Scientific and Technical Committee from among scientific

experts in the Member States 1 ,

Having regard to the opinion of the European Parliament 2 ,

Having regard to the opinion of the European Economic and Social Committee 3 ,

Whereas:

(1) Council Directive 2013/59/Euratom 4 lays down basic safety standards for the protection

against the dangers arising from exposure to ionising radiation.

(2) Following the accident at the Chernobyl nuclear power-station on 26 April 1986, considerable quantities of radioactive materials were released into the atmosphere, contaminating

foodstuffs and feeding stuffs in several European countries to levels significant from the health point of view. Measures were adopted to ensure that certain agricultural products are only introduced into the Union according to the common arrangements which safeguard the health of the population while maintaining the unified nature of the market and avoiding deflections of trade.

1 OJ C..p..

2 OJ C , , p. .

3 OJ C , , p. .

4 Council Directive 2013/59/Euratom of 5 December 2013 laying down basic safety

standards for protection against the dangers arising from exposure to ionising radiation, and repealing Directives 89/618 i/Euratom, 90/641 i/Euratom, 96/29 i/Euratom, 97/43/Euratom and 2003/122/Euratom (OJ L 13, 17.01.2014).

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(3) Council Regulation (Euratom) No 3954/87 5 lays down maximum permitted levels of

radioactive contamination to be applied following a nuclear accident or any other case of radiological emergency which is likely to lead or has led to significant radioactive contamination of food and feed. Those maximum permitted levels are still in line with the latest scientific advice as presently available internationally. The rationale and the assumptions which underline the maximum permitted levels of radioactive contamination of food have been reviewed by the Group of Expert referred to in Article 31 of the Euratom Treaty and are described in Publication RP 105 entitled "EU Food

Restriction Criteria for Application after an Accident 6 .

(4) Following the accident at the Fukushima nuclear power station on 11 March 2011, the

Commission was informed that radionuclide levels in certain food products originating in Japan exceeded the action levels in food applicable in Japan. Such contamination may constitute a threat to public and animal health in the Union and therefore measures were adopted imposing special conditions governing the import of feed and food originating in or consigned from Japan, in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.

(5) There is a need to set up a system allowing the European Atomic Energy Community, following a nuclear accident or any other case of radiological emergency which is likely to lead or has led to a significant radioactive contamination of food and feed, to establish maximum permitted levels of radioactive contamination regarding those products that could be placed on the market in order to protect the population.

(6) Maximum permitted levels of radioactive contamination should apply to food and feed originating in the Union or imported from third countries according to the location and circumstances of the nuclear accident or the radiological emergency.

5 Council Regulation (Euratom) No 3954/87 of 22 December 1987 laying down maximum

permitted levels of radioactive contamination of foodstuffs and of feedingstuffs following a nuclear accident or any other case of radiological emergency (OJ L 371, 30.12.1987, p. 11).

6 RP 105 is available on the following website:

http://ec.europa.eu/energy/nuclear/radiation_protection/publications_en.htm

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(7) The Commission is to be informed of a nuclear accident or of unusually high levels of

radioactivity according to Council Decision 87/600 i/Euratom 7 , or under the IAEA Convention

on early notification of a nuclear accident of 26 September 1986.

(8) In order to take into account that diets of infants during the first six months period of life may vary significantly, and to allow for uncertainties in the metabolism of infants during the

second six months period of life, there is a benefit in extending the application of lower maximum permitted levels for foods for infants, to the whole first 12 months of age.

(9) In order to facilitate the adaptation of maximum permitted levels, in particular with regard to the circumstances of the nuclear accidents or the radiological emergency scientific

knowledge, procedures for reviewing the implementing ragulations may establishing the maximum permitted levels should include the consultation by the Commission of the Group of Experts referred to in Article 31 of the Treaty.

(10) In order to ensure that food and feed exceeding the maximum permitted levels are not placed on the market of the EU, compliance with these levels should be the subject of appropriate

checks.

(11) In order to ensure uniform conditions for the implementation of this Regulation as regards rendering applicable the pre-established maximum permitted levels, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance

with Regulation (EU) No 182/2011 i 8 of the European Parliament and of the Council of 16

February 2011 laying down the rules and general principles concerning mechanisms for

control by the Member States of the Commission's exercise of implementing powers 9

[which is to should apply for the purpose of this Regulation, not withstanding the fact that even though it does not refer explicitly to mention Article 106a of the Euratom Treaty].

7 Council Decision 87/600 i/Euratom of 14 December 1987 on Community arrangements for the

early exchange of information in the event of radiological emergency (OJ L 371, 30.12.1987, p. 76).

8 Regulation (EU) No 182/2011 i 8 of the European Parliament and of the Council of 16

February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers

9 OJ L 55, 28.2.2011, p. 13.

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(12) The examination procedure should be used for the adoption of acts rendering applicable the pre-established maximum permitted levels of radioactive contamination of food and feed.

(13) The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to certain radiological emergencies which are likely to lead or have led to a significant radioactive contamination of food and feed, imperative grounds of urgency so require.

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter

This Regulation lays down:

(a) the maximum permitted levels of radioactive contamination of food as set out in Annex I, the maximum permitted levels of minor food as set out in Annex II, and the maximum permitted levels of radioactive contamination of feed as set out in Annex III, which may be placed on the market following a nuclear accident or any other case of radiological emergency which is likely to lead to or has led to significant radioactive contamination of food and feed, and

(b) the procedure to adopt or subsequently amend implementing regulations rendering the maximum permitted levels applicable.

Article 2

Definitions

For the purposes of this Regulation, the following definitions shall apply:

• 1) 

  ‘food’ (or ‘foodstuff’) means any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans. ‘Food’ includes drink, chewing gum and any substance, [including water], intentionally incorporated into the food during its manufacture, preparation or treatment. [It includes water after the point of compliance as defined in Article 6 of Directive 98/83/EC i and without prejudice to the requirements of Directives 80/778/EEC i and 98/83/EC].

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‘Food’ shall not include: (a) feed; (b) live animals unless they are prepared for placing on the market for human consumption; (c) plants prior to harvesting; (d) medicinal products within the meaning of Article 1(2) of Directive 2001/83/EC i of the

European Parliament and of the Council 10 Directives 65/65/EEC i (1) and 92/73/EEC

(2); (e) cosmetics within the meaning of Article 2(1)(a) of Regulation (EC) No 1223/2009 i of

the European Parliament and of the Council 11 Directive 76/768/EEC i (3);

(f) tobacco and tobacco products within the meaning of Directive 2001/37/EC i of the

European Parliament and of the Council 12 Directive 89/622/EEC i (4);

(g) narcotic or psychotropic substances within the meaning of the United Nations Single Convention on Narcotic Drugs, 1961, and the United Nations Convention on

Psychotropic Substances, 1971; (h) residues and contaminants.;

(i) [water intended for human consumption, in particular after the point of compliance as defined in Article 5 of Directive 2013/51 i/Euratom 13 ].

• 2) 

  "minor food" means food of minor dietary importance which makes only a marginal contribution to food consumption by the population;

• 3) 

  "feed" (or ‘feedingstuff”) means any substance or product, including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals as defined in regulations 183/2005 i and 767/2009;

10 Directive 2001/83/EC i of the European Parliament and of the Council of 6 November

2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).

11 Regulation (EC) No 1223/2009 i of the European Parliament and of the Council of 30

November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).

12 Directive 2001/37/EC i of the European Parliament and of the Council of 5 June 2001 on

the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco products (OJ L 194, 18.7.2001, p. 26).

13 [Council Directive 2013/51 i/Euratom of 22 October 2013 laying down requirements for

the protection of the health of the general public with regard to radioactive substances in water intended for human consumption].

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• 4) 

  "placing on the market" means the holding of food or feed for the purpose of sale, including offering for sale or any other form of transfer, whether free of charge or not, and the sale,

  distribution, and other forms of transfer themselves as defined in regulation 142/2009 i art 3.14 and in regulation 178/2009 i art 3.7.

• 5) 

  "emergency" means a non-routine situation or event involving a radiation source that necessitates prompt action to mitigate serious adverse consequences for human health and safety, quality of life, food- and feedsafety, property or the environment, or a hazard that could give rise to such serious adverse consequences;

Article 3

Applicable maximum permitted levels

• 1. 

  In the event of the Commission receiving — in particular according to either the European

  Atomic Energy Community arrangements for the early exchange of information in case of a radiological emergency or under the IAEA Convention of 26 September 1986 on early notification of a nuclear accident — official information on accidents or on any other case of radiological emergency, which is likely to lead or has led to radioactive contamination of substantiating that the maximum permitted levels for food, minor food or feed set out in Annexes I, II and III are likely to be reached or have been reached, the Commission shall adopt, if the circumstances so require, an implementing Regulation rendering applicable maximum permitted levels to the potentially contaminated food and feed products that could be placed on the market. The maximum permitted levels set out in the implementing Regulation shall not exceed those set out in Annexes I, II and III [without opinion of the Article 31 group of experts]. That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 5(2).

  On duly justified imperative grounds of urgency relating to the circumstances of the nuclear accident or the radiological emergency, the Commission shall adopt an immediately applicable implementing Regulation in accordance with the procedure referred to in Article 5(3).

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2. The period of validity of implementing Regulations adopted under paragraph 1 shall be as short as possible. The duration of the first implementing Regulation adopted

following a nuclear accident or radiological emergency shall not exceed three months.

Implementing Regulations shall be periodically reviewed by the Commission, and if appropriate, amended in accordance with the justification principle on the basis of the nature and location of the accident and of the evolution of the level of radioactive contamination effectively measured.

• 3. 

  When preparing the draft implementing Regulation referred to in paragraph 1, or reviewing it, the Commission shall take into account the basic standards laid down in accordance with Articles 30 and 31 of the Treaty, including the justification principle and the optimisation principle, with the aim of keeping the magnitude of individual doses, the likehood of

  exposure and the number of individuals exposed as low as reasonably achievable taking into account the current state of technical knowledge and economic and societal factors.

  When reviewing the implementing Regulations, the Commission may seek the opinion of the Group of Experts referred to in Article 31 of the Treaty establishing the European Atomic Energy Community, in particular in the event of a nuclear accident or a radiological emergency causing such a widespread contamination of food consumed in the EU that the rationale and assumptions behind the maximum permitted levels set out in Annexes I, II and III are no longer valid.

3a. Without prejudice to the objective pursued by this Regulation, implementing

Regulations may allow at EU level for derogations to [or below] the maximum permitted levels [set out in Annexes I, II and III / set out therein] for specific food or feed. Those derogations based on cultural and societal considerations shall be objectively justified and shall only apply to food or feed which are of [minor importance] at the Community level is produced and consumed locally in a Member State.

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Article 4

Restrictive measures

• 1. 

  As soon as the Commision adopts an implementing Regulation rendering applicable maximum permitted levels, food or feed not in compliance with those maximum permitted levels shall not be placed on the market.

  For the purposes of applying this Regulation, food or feed intended for import into the Union imported from third countries shall be deemed as intended for placing considered to be placed on the market when it arrives at any entry point into the EU, unless the importer provides evidence to the contrary. The final decision shall be one for the competent authority at the point of entry to the Union if, on the customs territory of the Union, they undergo a customs procedure other than a transit procedure.

• 2. 

  Each Member State shall provide the Commission through the Urgent Radiological

  Information Exchange system (ECURIE) or the Rapid Alert System for Food and Feed with all information concerning the application of this Regulation,. The Commission shall communicate such information to other Member States. in particular concerning cCases of non-compliance with the maximum permitted levels shall be notified through the Rapid Alert System for Food and Feed (RASFF). The Commission shall communicate such information to the other Member States.

3. In addition to § 1 and 2, and if required by the circumstances, the Commission might impose additional measures and special conditions governing the import of food and feed such as declaration of consignments and prior notification of their arrival

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Article 5 Committee

• 1. 

  The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health established by Article 58 (1) of Regulation (EC) No 178/2002 i of the European

Parliament and of the Council 14 . That committee shall be considered as a committee within

the meaning of Regulation (EU) No 182/2011 i[and its members composition shall ensure

that the committee has the necessary expertise in the field of radiation protection].

• 2. 

  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 i shall apply.

• 3. 

  Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011 i, in conjunction with Article 5 thereof, shall apply.

  Article 6 Reporting In case of a nuclear accident or any other case of a radiological emergency, the Commission shall submit to the European Parliament and to the Council a report on the implementation of the measures undertaken pursuant to this Regulation and notified to the Commission according to Article 4.2.

Article 7

Council Regulation (Euratom) No 3954/87 and Commission Regulations (Euratom) No 944/89 and No 770/90 are repealed.

References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex IV.

14 Regulation (EC) No 178/2002 i of the European Parliament and of the Council of 28 January

2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).

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Article 8

This Regulation shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the Council The President […]

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Annex 0 to ANNEX

ANNEX 0

The maximum contamination levels set out in Annexes I to III were derived from Report 105 (EU Food Restriction Criteria for Application after an Accident, Radiation Protection 105 of 1998). These are based in particular on the following assumptions:

1. It is assumed that 10% of food is contaminated; different assumptions apply to infants under one year.

2. The basis for dose estimates are the dose co-efficients of the radionuclides for ingestion, an average annual consumption quantity for certain food groups and the assumed percentage of contaminated food.

3. The dose criterion is based on an additional dose of 5 mSv for adults as well as for infants.

4. Sum formulae should be used to set maximum permitted levels and to review compliance with these levels.

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Annex 0 to ANNEX DG E EN

Annex Ι to ANNEX ANNEX I

MAXIMUM PERMITTED LEVELS OF RADIOACTIVE CONTAMINATION OF FOOD

The maximum permitted levels to be applied to food shall be the following:

Isotope group/Food Food (Bq/kg) 15

group

 Infant food 16 Dairy Other food Liquid food 19 produce 17 except minor

food 18

Sum of Iisotopes of 75 125 750 125 strontium, notably Sr-90 Sum of Iisotopes of 150 500 2 000 500 iodine, notably I-131 Sum of Alpha 1 20 80 20 emitting isotopes of plutonium and transplutonium elements, notably Pu-239, Am-241 Some of Aall other 400 1 000 1 250 1 000 nuclides of half-life greater than 10 days, notably

Cs-134, Cs-137 20

15 The level applicable to concentrated or dried products is calculated on the basis of the

reconstituted product as ready for consumption. Member States may make recommendations concerning the diluting conditions in order to ensure that the maximum permitted levels laid down in this Regulation are observed.

16 Infant food is defined as those foodstuffs intended for the feeding of infants during the first

twelve months of life, which meet, in themselves, the nutritional requirements of this category of person and are put up for retail sale in packages which are clearly identified and labelled as

such.

17 Dairy produce is defined as those products falling within the following CN codes including,

where appropriate, any adjustments which might be made to them later: 0401, 0402 (except 0402 29 11).

18 Minor food and the corresponding levels to be applied to them are set out in Annex II.

19 Liquid food as defined in the heading 2009 and in chapter 22 of the combined nomenclature.

Values are calculated taking into account consumption of tap-water [and the same values should be applied to drinking water supplies at the discretion of competent authorities in Member States].

20 Carbon 14, tritium and potassium 40 are not included in this group.

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Annex 1 to ANNEX DG E EN

Annex II to ANNEX

ANNEX II

MAXIMUM PERMITTED LEVELS OF RADIOACTIVE CONTAMINATION OF MINOR

FOOD

• 1. 

  List of minor food

  CN code Description

0703 20 00 Garlic (fresh or chilled))

0709 59 50 Truffles (fresh or chilled)

0709 99 40 Capers (fresh or chilled)

0711 90 70 Capers (provisionally preserved, but unsuitable in that state for immediate consumption)

ex 0712 39 00 Truffles (dried, whole, cut, sliced, broken or in powder, but not further prepared)

0714 Manioc, arrowroot, salep, Jerusalem artichokes, sweet potatoes and similar roots and tubers with high starch or inulin content, fresh, chilled, frozen or dried, whether or not sliced or in the form of pellets; sago pith

0814 00 00 Peel of citrus fruit or melons (including watermelons), fresh, frozen, dried or provisionally preserved in brine, in sulphur water or in other preservative solutions

0903 00 00 Maté

0904 Pepper of the genus Piper; dried or crushed or ground fruits of the genus Capsicum or of the genus Pimenta

0905 00 00 Vanilla

0906 Cinnamon and cinnamon-tree flowers

0907 00 00 Cloves (whole fruit, cloves and stems)

0908 Nutmeg, mace and cardamons

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Annex II to ANNEX DG E EN

0909 Seeds of anise, badian, fennel, coriander, cumin or caraway; juniper berries

0910 Ginger, saffron, turmeric (curcuma), thyme, bay leaves, curry and other spices

1106 20 Flour, meal and powder of sago or of roots or tubers of heading No 0714

1108 14 00 Manioc (cassava) starch

1210 Hop cones, fresh or dried, whether or not ground, powdered or in the form of pellets; lupulin

1211 Plants and parts of plants (including seeds and fruits), of a kind used primarily in perfumery, in pharmacy or for insecticidal, fungicidal or similar purposes, fresh or dried, whether or not cut, crushed or powdered

1301 Lac; natural gums, resins, gum-resins and oleoresins (for example, balsams)

1302 Vegetable saps and extracts; pectic substances, pectinates and pectates; agar-agar and other mucilages and thickeners, whether or not modified, derived from vegetable products

1504 Fats and oils and their fractions, of fish or marine mammals, whether or not refined, but not chemically modified

1604 31 00 Caviar

1604 32 00 Caviar substitutes

1801 00 00 Cocoa beans, whole or broken, raw or roasted

1802 00 00 Cocoa shells, husks, skins and other cocoa waste

1803 Cocoa paste, whether or not defatted

2003 90 10 Truffles (prepared or preserved otherwise than by vinegar or acetic acid)

2006 00 Vegetables, fruit, nuts, fruit-peel and other parts of plants, preserved by sugar (drained, glacé or crystallized)

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2102 Yeasts (active or inactive); other single-cell micro-organisms, dead (but not including vaccines of heading No 3002); prepared baking powders

2936 Provitamins and vitamins, natural or reproduced by synthesis (including natural concentrates), derivatives thereof used primarily as vitamins, and intermixtures of the foregoing, whether or not in any solvent

3301 Essential oils (terpeneless or not), including concretes and absolutes; resinoids; extracted oleoresins; concentrates of essential oils in fats, in fixed oils, in waxes or the like, obtained by enfleurage or maceration; terpenic by-products of the deterpenation of essential oils; aqueous distillates and aqueous solutions of essential oils

• 2. 

  The maximum permitted levels to be applied to the minor food as listed in paragraph 1, shall be the following

  Isotope group (Bq/kg)

  Sum of Iisotopes of strontium, notably Sr-90 7500

  Sum of Iisotopes of iodine, notably I-131 20000

  Sum of Aalpha-emitting isotopes of plutonium 800 and transplutonium elements, notably Pu-239, Am-241

  Sum of Aall other nuclides of half-life greater 12500

  than 10 days, notably Cs-134, Cs-137 21

21 Carbon 14, tritium and potassium 40 are not included in this group.

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Annex II to ANNEX DG E EN

Annex III to ANNEX

ANNEX III

M AXIMUM PERMITTED LEVELS OF RADIACTIVE CONTAMINATION OF FEED

The maximum permitted levels for the sum of caesium-134 and caesium-137 shall be the following:

Animal Feed for Bq/kg 22, 23

Pigs 1 250

Poultry, lambs, calves 2 500

Other 5 000

22 These levels are intended to contribute to the observance of the maximum permitted levels for

food; they do not alone guarantee such observance in all circumstances and do not lessen the requirement for monitoring contamination levels in animal products destined for human consumption.

23 These levels apply to feed as ready for consumption.

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Annex III to ANNEX DG E EN

Annex IV to ANNEX

ANNEX IV

C ORRELATION T ABLE Regulation (Euratom) Regulation (Euratom) Regulation (Euratom) This Regulation

No 3954/87 No 944/89 No 770/90 Article 1(1) Article 1

Article 1 Article 1 Article 1(2) Article 2 Article 2(1) Article 3(1) and

3(2) Article 2(2) -

Article 3(1) -

Article 3(2) Article 3(3)

Article 3(3) and (4) -

Article 4 -

Article 5(1) Article 6

Article 5(2) -

Article 6(1) Article 4(1)

Article 6(2) Article 4(2)

Article 2 Annex II(2) Article 1 Annex III

--- --- --- Article 5

Article 7 -

--- --- --- Article 7

Article 8 Article 8

Annex Annex I

Annex Annex II(1) Annex Annex III

--- --- --- Annex IV

--- --- --- Annex V

_______________

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Annex IV to ANNEX DG E EN